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Impact Ureteral Sheath Design During Ureteroscopy

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ClinicalTrials.gov Identifier: NCT03349099
Recruitment Status : Completed
First Posted : November 21, 2017
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Manoj Monga, MD, The Cleveland Clinic

Brief Summary:

The purpose of this study is to assess whether one of two ureteral access sheaths is safer for patients undergoing ureteroscopy. Both sheaths are FDA approved devices and commercially available. The investigators will compare the ability of sheaths to access the kidney through the ureter and will compare damage done to the ureter after completion of the procedure. Access sheaths are standard of care for this procedure; this study seeks to optimize outcomes for patients.

Patients undergoing ureteroscopy who do not have ureteral stents in place and who have not had an ipsilateral procedure within 90 days will be recruited and consented.


Condition or disease Intervention/treatment Phase
Renal Stone Nephrolithiasis Urolithiasis Device: Cook Flexor Device: Boston Scientific Navigator Not Applicable

Detailed Description:

The purpose of this study is to compare two ureteral access sheaths in how the sheaths damage the ureter during flexible ureteroscopy.

Condition Intervention Kidney Stones Nephrolithiasis Urolithiasis Device: Cook Flexor or Boston Scientific Navigator HD

Study Type: Interventional Study Design: Intervention Model: Two group randomized assignment Masking: Single blind Primary Purpose: Treatment

Primary Outcome Measures:

• Successful placement of sheath (yes or no).

Secondary Outcome Measures:

  • Subjective rating of damage to ureter. At the completion of the procedure, video of the intraluminal ureter is recorded as the sheath is withdrawn. Videos are analyzed by two blinded staff endourologists to score ureteral injury on a standard 5-point scale (0 to 4); reference Traxer and Thomas.
  • Ease of placement of each sheath. Surgeons will be asked to subjectively rate the ease of placement on a standardized scale from 0 to 4, 4 being easiest which will be rated by the surgeon who inserted the sheath immediately after placement.

Arms Assigned Interventions Device: Cook Flexor and Boston Scientific Navigator HD Device: Cook Flexor or Boston Scientific Navigator HD Patients will be assigned to one of two ureteral access sheaths. If the first sheath is failed to be placed, the backup sheath will be attempted.

Standard ureteroscopy will take place. The intervention takes place before the ureteral access sheath is placed. The patient will be randomized to one of the two sheaths. The randomized 12/14Fr sheath will be attempted. If placed successfully, the rest of the operation continues as planned. If the initial sheath is unable to be placed, a second backup sheath (opposite brand) will be used, also in size 12/14Fr. The surgeon will be asked to rate the ease of placement of the sheath on a standardized scale. If these sheaths fail, it is the surgeon's discretion to continue with the smaller sheath, continue without sheath or place stents and attempt the procedure at a later date. The operation is then continued in standard fashion. Once the ureteroscopy is completed, before the scope and access sheath are removed, video recording of the ureter will be conducted as the ureteroscopy and sheath are removed.

Videos will be analyzed by blinded urologists who will rate the extent of ureteral damage on a standardized scale of 0 to 4 according to the study published by Traxer et al. 2013. Intra-operative data includes total time of initial sheath insertion (in seconds), total time sheath is in place (minutes) from placement to removal, and use of laser. Differences in operative time, ease of placement, ability to maintain access, and ease of instrument passage are also evaluated between devices, as well as success rates, and device failure rates and post-operative complications. Means are compared using a t-test and proportions are compared using a chi-squared test. An intention to treat model is used for statistical analysis. When video ratings differ between surgeons, the higher rating of damage will be used. Inter-rater reliability is assessed with Cohen's kappa coefficient.

After the study, subjects will not be contacted. The investigators will collect data from participants' medical records including information of whether participants develop complications or return for a subsequent procedure as well as size and location of kidney stones prior to the surgery.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Videos will be analyzed by blinded urologists who will rate the extent of ureteral damage on a standardized scale of 0 to 4 according to the study published by Traxer et al. 2013. After the study, subjects will not be contacted.
Primary Purpose: Treatment
Official Title: The Impact of Ureteral Access Sheath Design on Ease of Placement and Ureteral Wall Injury During Flexible Ureteroscopy
Actual Study Start Date : June 27, 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cook Flexor
ureteral access sheath
Device: Cook Flexor
ureteral access sheath

Active Comparator: Boston Scientific Navigator HD
ureteral access sheath
Device: Boston Scientific Navigator
ureteral access sheath




Primary Outcome Measures :
  1. Number of Participants With Successful Sheath Placement [ Time Frame: One time point - at the beginning of the procedure ]
    The surgeon documents whether there was Successful placement of sheath (yes or no)


Secondary Outcome Measures :
  1. Number of Participants With Injury to the Ureter [ Time Frame: One time point - at the completion of the procedure ]
    Subjective rating of damage to ureter. At the completion of the procedure, video of the intraluminal ureter is recorded as the sheath is withdrawn. Videos are analyzed by two blinded staff endourologists who score ureteral injury on a standard 5-point scale (0 to 4); reference Traxer and Thomas.

  2. Ease of Sheath Placement [ Time Frame: One time point - at the completion of the procedure ]
    Surgeons will be asked to subjectively rate the ease of placement on a standardized scale from 0 to 4, 4 being easiest which will be rated by the surgeon who inserted the sheath immediately after placement.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients planned for ureteroscopy
  • Current CT scan within 90-days before the operation
  • Able to give informed consent
  • Ages 18 years and older

Exclusion Criteria:

  • Inability to give informed consent
  • Age less than 18 years
  • Pregnant
  • Stones in the ureter
  • Having previous ipsilateral ureteral or renal surgery within 90 days
  • Having stents placed in ipsilateral ureter within 90 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349099


Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Manoj Monga, MD Urologist
  Study Documents (Full-Text)

Documents provided by Manoj Monga, MD, The Cleveland Clinic:
Informed Consent Form  [PDF] May 31, 2014


Publications:

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Responsible Party: Manoj Monga, MD, Director of Endourology and Stone Disease, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03349099     History of Changes
Other Study ID Numbers: 14-632
First Posted: November 21, 2017    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Nephrolithiasis
Kidney Calculi
Urolithiasis
Kidney Diseases
Urologic Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical